The launch of Zentiva in Nigeria, the third largest and fastest growing generics company in Europe, by Sanofi, is seen as a move to ameliorate the plight of many, for whom affordable healthcare was out of reach. Writes Mary Ekah

Records abound of unavoidable and untimely deaths traced to a number of factors including counterfeit or adulterated drugs and lack of access to qualitative medicines because they are either out of reach of the patient in terms of availability and affordability. The wide availability and affordability of drugs have been highly linked to achieving not only the sustainable development goals of health, but also sustainable development goals in general.

Access to affordable and qualitative drugs remains a challenge, especially in developing and underdeveloped nations. A paper on the United Nation’s Secretary-General’s high level panel on access to medicines states that lack of political will and poor regulation makes Nigeria a market for substandard and counterfeit drugs. The panel further described access to drugs as one of the greatest public health challenges of our time.

A report by the Department for International Development (DFID) revealed that people lack access to medicines where they cannot obtain the products they need to prevent or treat a medical condition. According to the report, this scenario might be because a product is unavailable or is not offered, or because it is unaffordable. Many medicines needed to treat ailments remain largely unavailable or inaccessible for many.

These and many other factors contribute to the high level of access to healthcare, thus ensuring that majority of the populace cannot either take preventive measures, to make themselves immune against certain diseases; or afford treatment, in the event that they fall ill and require treatment. In some extreme instances, affordable healthcare is seen as a mirage.

To this end, Zentiva, recently launched by Sanofi, is seen as a move to ameliorate the plight of many, for whom affordable healthcare was out of reach.  The introduction of Zentiva in Nigeria has been described as a move towards alleviating the challenges of accessibility and affordability of quality drugs, which a lot of Nigerians are confronted with. Zentiva, which is the third largest and fastest, growing Generics Company in Europe, is at the forefront of developing modern and affordable medicines.

The Managing Director of Sanofi Nigeria-Ghana, Mr. Abderrahmane Chikabi, was unequivocal when he stated that the subject of health economics remains a topical issue among stakeholders. Indeed, the issue of how to provide sustainable universal health coverage to patients remains a course of concern for stakeholders in the health industry; amongst whom are government officials, public decision makers, researchers, drug manufacturers, healthcare managers and the like.

At the official launch of Zentiva, he made reference to earlier reports, which indicated that a significant portion of the population in sub – Sahara Africa cannot afford basic healthcare and also have limited access to efficacious medicines; just as the burdens of infectious diseases such as malaria, HIV AIDS and tuberculosis persist. He further alerted on the dangers of counterfeit and adulterated drugs not only to the patients and individuals but also quantified it in terms of economic loss to the nation.

“Counterfeit and adulterated medicines are part of the health and challenges. It has been estimated that not less than 30 per cent of medicines in Sub-Saharan Africa are counterfeit, adulterated, substandard, illegally imported or mislabeled. The use of these medicines may lead to therapeutic failures, prolonged hospitalisation, development of complications or adverse events and may ultimately give rise to increased healthcare costs to the patients”, Chikabi noted.

He reasoned that these negative factors put significant social and economic pressures on governments, donor agencies, healthcare providers, patients and their families, adding that the resultant effect is that governments will have to grapple with the challenges of rising healthcare costs in the face of an ever-increasing population.

Speaking on the role of Sanofi, he said that the company continually responds to the challenge protecting the health of the populace. “Our ambition is to increase access to healthcare through the provision of innovative medicines and disease management expertise.”

He further said that the company partners stakeholders such as health authorities, healthcare practitioners, public and private health institutions, non-governmental organisations and patients. He further stated that the company continues to invest in research and development in order to discover and develop new therapeutic solutions to tackle emerging health challenges.

Speaking on the rationale behind the launch of Zentiva, the Sanofi MD stated that it was in line with the company’s strategy to continually provide safe, effective and cost-effective drugs to support in driving down overall healthcare costs. He declared that the ‘unveil’ of the company’s rich portfolio of quality and cost-effective generic medicines under the Zentiva identity was a direct reinforcement of Sanofi’s access to healthcare ambitions.

 “Zentiva is a Sanofi company. Zentiva is an international leader that develops, produces and distributes cost-effective generic medicines that improve and prolong the lives of more patients in more countries. It is a brand of proven efficacy, manufactured to the highest international quality standards and are duly registered with NAFDAC in Nigeria”, he said, adding, that Zentiva offers one of the broadest generic product portfolios for major therapeutic areas including cardiovascular, endocrine, female health, respiratory, anti-infectives and anti-fungals, urology, central nervous system, pain and gastrointestinal.

Chakibi advocated that quality healthcare should not be out of reach of the populace.  “Quality healthcare does not necessarily need to be expensive. Our people deserve to have access to the best quality but yet most cost-effective medicines possible. With our extensive and secure distribution network, and unique expertise of our workforce and trade partners, Sanofi is strategically positioned to make the Zentiva brands available to all who need it in Nigeria” he said.

In a paper titled: “It does matter what’s inside”, Director, Drug Evaluation and Research of the National Agency for Food and Drug Administration and Control (NAFDAC), Mrs. Titilope Owolabi, described accessibility to essential medicines of assured quality as a key indicator of equity and social justice. According to her, the goal of pharmaceutical development is to design a quality product and to ensure that its manufacturing processes and controls consistently deliver the intended performance of the product that meets consumer expectations.

Owolabi further outlined the phases involved in the product life cycle of a pharmaceutical drug viz: pharmaceutical development, technology transfer, manufacturing and then the discontinuation stage. She further explained that NAFDAC’s expectations as captured in extant regulations are that manufacturers of pharmaceuticals will adhere to good manufacturing practice requirements and ensure the quality of pharmaceutical products that are fit for intended use, comply with marketing authorisation requirements and do not place the consumers at risk.

She added that the overall essence of NAFDAC’s stringent oversight supervision was to ensure that pharmaceutical products meet the requirements of safety, quality and efficacy they purport or are presented to possess.

According to her, the innovative or branded drugs have undergone the process of research and development and have been patented; while generic drugs are the copies of original marketed products on which the patents have expired and therefore can be marketed as equivalent to and therefore can be used in place of the original. She further stated that generic drugs are subjected to the same level of scrutiny as the branded drugs and therefore must undergo the same quality assurance process tests.

Owolabi said, “Despite the cost of the generic drugs, the quality, safety and efficacy are never compromised. There is no evidence that branded (innovative) drugs are superior to generic drugs. Many generic drugs are manufactured in the same production facilities as the brand name drugs.”

Owolabi said the generic drugs should be bioequivalent to the innovator in dosage form, safety, strength, quality, performance characteristics, route of administration and intended use.In an attempt to correct the notion in some quarters that generic drugs are inferior, Owolabi stated generic drugs are subjected to stringent manufacturing and packaging tests just like branded drugs. She stated that while generics drugs are cheaper than branded drugs, this does not mean they are of lower quality.

 “Despite the low cost of the generic drugs, the quality, safety and efficacy are never compromised. This is ensured by the conduct of bioavailability/bioequivalence study on the generics as well as ensuring that the manufacture conforms to good manufacturing practice”, she said.

For a generic drug to be granted marketing authorisation is must be quantitatively and qualitatively similar to the comparator or branded medicine. While affirming that several studies have found no evidence that brand-name drugs are superior to generic drugs with respect to clinical outcomes, she however cautioned that there have been cases of failures with respect to both branded and generic drugs. She pointed out that many generic drugs are manufactured in the same facilities as branded drug products.

Speaking on the further benefits of generic drugs she said they allow patients to access safe, effective and high quality medicines at an affordable cost.

She said generic drug are affordable because their manufacturing companies incur lower sales and marketing expenses while they also benefit from a market already established by the branded drug manufacturing company.
Owolabi reiterated that promoting generics can help meet the objectives of health sector reforms by improving affordability, reducing cost, increasing choice and helping to rationalise both the selection and use of medicines, she affirmed that: “NAFDAC is well-positioned to ascertain the safety, quality, efficacy, purity and potency of any medicine in order to safeguard the health of the nation.”

Mr. Gabriel Ogunyemi, the Head of the Primary Care Business Unit of Sanofi Nigeria-Ghana, said Zentiva’s strategy is hinged on quality, affordability and efficacy, guaranteed by Sanofi. He assured that Zentiva’s portfolio of generic drugs are effective and have the same potency as branded innovative drugs. He however added that Sanofi Nigeria would remain as the legal entity.